SD0001: No records in data source

m Marina

on November 29, 2018

Hello!

I have the annotated CRF with specific domains, but for some of them there is no data. What should I do in this situation? Should the empty datasets be submitted and described in the define.xml document?

Thank you!

Forums: SDTM

s Sergiy

on November 29, 2018

No, empty datasets should not be submitted

Hi Marina,

No, empty datasets should not be submitted.

To document your case you need to use Reviewer's Guide where is a special question if all planned to collect data are included?

Kind Regards,

Sergiy

l Lex

on November 29, 2018

HasNoData

Just to add, Define-XML 2.1 will have a HasNoData attribute on the ItemGroup element that can be used in this case. When HasNoData=“Yes”, no dataset is expected to exist.

Best, Lex